BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIONEER SURGICAL STREAMLINE MIS SYSTEM

    MDR report key: 10058384 · Received May 14, 2020

    Report

    Report Number
    1833824-2020-00021
    Event Type
    Injury
    Date Received
    May 14, 2020
    Date of Event
    February 14, 2019
    Report Date
    May 14, 2020
    Manufacturer
    PIONEER SURGICAL (D.B.A. RTI SURGICAL)
    Product Code
    NKB
    UDI-DI
    00846468052515
    PMA / PMN Number
    K130286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED SCREW WAS NOT RETURNED TO RTI SURGICAL FOR EVALUATION. A DHR REVIEW WAS CONDUCTED AND CONFIRMED THAT THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO SHIPPING FROM RTI SURGICAL. ON APRIL 15, 2020 RTI SURGICAL MQT WAS ABLE TO CONFIRM THAT HARDWARE DID BREAK WITHIN THE PATIENT. 1 OF 2 MDRS REPORTED FOR THIS OCCURRENCE. THE 2ND MDR IS ON REPORT NUMBER 1833824-2020-00022.

    Description of Event or Problem · 1

    A REVISION SURGERY TOOK PLACE ON (B)(6) 2019 TO REMOVE BROKEN HARDWARE. INDEX SURGERY WAS PERFORMED ON (B)(6) 2017. THE PATIENT REPORTED PAIN IN (B)(6) OF 2018 WHERE "THERE WAS EVIDENCE OF L5-S1 INTERVERTEBRAL HARDWARE SUBSIDENCE PROJECTING INTO THE INTERIOR L5 VERTEBRAL BODY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520745 PIONEER SURGICAL STREAMLINE MIS SYSTEM PEDICLE SCREW NKB PIONEER SURGICAL (D.B.A. RTI SURGICAL) 05-PA-75-40 262465 00846468052515

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Congenital Anomaly| H